FIFRA Scientific Advisory Panel; Notice of Public Meeting, 74901-74904 [E6-21201]
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Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Notices
hsrobinson on PROD1PC76 with NOTICES
Changes Since the Preliminary Results
Based on our analysis of comments
received, we adjusted the calculation
methodology used in the Preliminary
Results. First, we calculated general and
administrative expenses (G&A) and
interest expenses based on LM’s
financial statements for the Fiscal Year
2005, which is the time period that most
closely corresponds to the POR. Second,
we moved expenses for LM’s football
and hockey clubs from G&A expenses to
indirect selling expenses because these
clubs provide indirect advertising
benefits to the company. Finally, we
adjusted the calculation of the variable
cost of manufacturing in the margin
calculation program to account for a
clerical error. These adjustments are
discussed in detail in the Decision
Memorandum.
this clarification, see Antidumping and
Countervailing Duty Proceedings:
Assessment of Antidumping Duties, 68
FR 23954 (May 6, 2003).
Cash Deposits
Furthermore, the following deposit
requirements will be effective upon
publication of the final results of this
administrative review for all shipments
of rebar from Latvia entered, or
withdrawn from warehouse, for
consumption on or after the publication
date of these final results, as provided
by section 751(a) of the Tariff Act of
1930, as amended (the Act): (1) For LM,
the cash deposit rate will be 5.94
percent; (2) for merchandise exported by
producers or exporters not covered in
this review but covered in a previous
segment of this proceeding, the cash
deposit rate will continue to be the
Final Results of Review
company–specific rate published in the
most recent final results in which that
As a result of our review, we
producer or exporter participated; (3) if
determine that the following weighted–
the exporter is not a firm covered in this
average margin exists for the period of
review or in any previous segment of
September 1, 2004, through August 31,
this proceeding, but the producer is, the
2005:
cash deposit rate will be that established
for the producer of the merchandise in
Weighted–Average
Producer
these final results of review or in the
Margin (Percentage)
most recent final results in which that
Joint Stock Company
producer participated; and (4) if neither
Liepajas Metalurgs
5.94 the exporter nor the producer is a firm
covered in this review or in any
Assessment
previous segment of this proceeding, the
cash deposit rate will be 17.21 percent,
The Department will determine, and
the ‘‘All Others’’ rate established in the
U.S. Customs and Border Protection
less–than-fair–value investigation.
(CBP) shall assess, antidumping duties
These deposit requirements shall
on all appropriate entries, pursuant to
remain in effect until publication of the
19 CFR 351.212(b). The Department
final results of the next administrative
calculated importer–specific duty
assessment rates on the basis of the ratio review.
This notice also serves as a final
of the total amount of antidumping
duties calculated for the examined sales reminder to importers of their
responsibility under 19 CFR 351.402(f)
to the total entered value of the
examined sales for that importer. Where to file a certificate regarding the
the assessment rate is above de minimis, reimbursement of antidumping duties
we will instruct CBP to assess duties on prior to liquidation of the relevant
entries during this review period.
all entries of subject merchandise by
Failure to comply with this requirement
that importer. The Department intends
could result in the Secretary’s
to issue assessment instructions to CBP
presumption that reimbursement of
15 days after the date of publication of
antidumping duties occurred, and in the
these final results of review.
The Department clarified its
subsequent assessment of double
‘‘automatic assessment’’ regulation on
antidumping duties.
This notice also is the only reminder
May 6, 2003 (68 FR 23954). This
to parties subject to administrative
clarification will apply to entries of
protective order (APO) of their
subject merchandise during the POR
responsibility concerning the return or
produced by companies included in
destruction of proprietary information
these preliminary results of review for
disclosed under APO in accordance
which the reviewed companies did not
with 19 CFR 351.305. Timely written
know their merchandise was destined
for the United States. In such instances, notification of the return/destruction of
the Department will instruct CBP to
APO materials or conversion to judicial
liquidate unreviewed entries at the all–
protective order is hereby requested.
others rate if there is no rate for the
Failure to comply with the regulations
intermediate company(ies) involved in
and the terms of an APO is a
the transaction. For a full discussion of
sanctionable violation.
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We are issuing and publishing these
results and notice in accordance with
sections 751(a)(1) and 777(i)(1) of the
Act.
Dated: December 6, 2006.
David M. Spooner,
Assistant Secretaryfor Import Administration.
Appendix
Comment 1: Use of Monthly Cost
Comparison Periods
Comment 2: Date of Sale
Comment 3: General and Administrative
Expense Ratio Calculation
Comment 4: Clerical Error
Comment 5: Treatment of Non–Dumped
Sales
Comment 6: Financial Statements Used
for General and Administrative
Expenses and Interest Expenses
[FR Doc. E6–21205 Filed 12–12–06; 8:45 am]
BILLING CODE 3510–DS–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2006–0987; FRL–8107–9]
FIFRA Scientific Advisory Panel;
Notice of Public Meeting
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: There will be a 2–day meeting
of the Federal Insecticide, Fungicide,
and Rodenticide Act Scientific Advisory
Panel (FIFRA SAP) to consider and
review the status of the in utero through
lactational assay in the Endocrine
Disruptor Screening Program (EDSP).
DATES: The meeting will be held on
February 27-28, 2007, from 8:30 a.m. to
5 p.m, eastern time.
Comments: The Agency encourages
submission of written comments by
February 13, 2007 and requests for oral
comments by February 20, 2007.
However, written comments and
requests to make oral comments may be
submitted until the date of the meeting.
For additional instructions, see Unit I.C.
of the SUPPLEMENTARY INFORMATION.
Nominations: Nominations of
candidates to serve as ad hoc members
of the FIFRA SAP for this meeting
should be provided on or before
December 26, 2006.
Special Accommodations: For
information on access or services for
individuals with disabilities, and to
request accommodation of a disability,
please contact the Designated Federal
Official (DFO) listed under FOR FURTHER
INFORMATION CONTACT at least 10 days
prior to the meeting to give EPA as
much time as possible to process your
request.
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The meeting will be held at
the Environmental Protection Agency,
Conference Center - Lobby Level, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Drive, Arlington, VA 22202.
Comments: Submit your comments,
identified by docket ID number EPA–
HQ–OPP–2006–0987, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
Your use of the Federal eRulemaking
Portal to submit comments to EPA
electronically is EPA’s preferred method
for receiving comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., N.W., Washington,
DC 20460-0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S-4400, One
Potomac Yard (South Bldg), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 3055805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2006–
0987. If your comments contain any
information that you consider to be CBI
or otherwise protected, please contact
the DFO listed under FOR FURTHER
INFORMATION CONTACT to obtain special
instruction before submitting your
comments. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The regulations.gov website is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
regulations.gov, your e-mail address
will be automatically captured and
included as part of the comment that is
placed in the docket and made available
on the Internet. If you submit an
electronic comment, EPA recommends
that you include your name and other
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ADDRESSES:
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contact information in the body of your
comment and with any disk or CD ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in a docket index that is
available at https://www.regulations.gov.
Although listed in a docket index, some
information is not publicly available,
e.g., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Bldg), 2777 S.
Crystal Drive, Arlington, VA. The hours
of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket telephone number
is (703) 305-5805.
Nominations, requests to present oral
comments, and requests for special
accommodations: Submit nominations
to serve as an ad hoc member of the
FIFRA SAP, requests for special seating
accommodations, or requests to present
oral comments to the DFO listed under
FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT:
William Wooge, DFO, Office of Science
Coordination and Policy (7201M),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460; telephone number: 202-5648476; fax number: 202-564-8382; e-mail
addresses: wooge.william@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public
in general. This action may, however, be
of interest to persons who are or may be
required to conduct testing of chemical
substances under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
FIFRA, and the Food Quality Protection
Act of 1996 (FQPA). Since other entities
may also be interested, the Agency has
not attempted to describe all the specific
entities that may be affected by this
action. If you have any questions
regarding the applicability of this action
to a particular entity, consult the DFO
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listed under FOR FURTHER INFORMATION
CONTACT.
B. What Should I Consider as I Prepare
My Comments for EPA?
Tips for preparing your comments.
When submitting comments, remember
to:
1. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
2. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
3. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
4. Describe any assumptions and
provide any technical information and/
or data that you used.
5. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
6. Provide specific examples to
illustrate your concerns and suggest
alternatives.
7. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
8. Make sure to submit your
comments by the comment period
deadline identified.
C. How May I Participate in this
Meeting?
You may participate in this meeting
by following the instructions in this
unit. To ensure proper receipt by EPA,
it is imperative that you identify docket
ID number EPA–HQ–OPP–2006–0987 in
the subject line on the first page of your
request.
1. Written comments. The Agency
encourages that written comments be
submitted, using the instructions in
ADDRESSES, no later than February 13,
2007, to provide FIFRA SAP the time
necessary to consider and review the
written comments. However, written
comments are accepted until the date of
the meeting. Persons wishing to submit
written comments at the meeting should
contact the DFO listed under FOR
FURTHER INFORMATION CONTACT and
submit 30 copies. There is no limit on
the extent of written comments for
consideration by FIFRA SAP.
2. Oral comments. The Agency
encourages that each individual or
group wishing to make brief oral
comments to the FIFRA SAP submit
their request to the DFO listed under
FOR FURTHER INFORMATION CONTACT no
later than February 20, 2007, in order to
be included on the meeting agenda.
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Requests to present oral comments will
be accepted until the date of the meeting
and, to the extent that time permits, the
Chair of the FIFRA SAP may permit the
presentation of oral comments at the
meeting by interested persons who have
not previously requested time. The
request should identify the name of the
individual making the presentation, the
organization (if any) the individual will
represent, and any requirements for
audiovisual equipment (e.g., overhead
projector, 35 mm projector, chalkboard).
Oral comments before FIFRA SAP are
limited to approximately 5 minutes
unless prior arrangements have been
made. In addition, each speaker should
bring 30 copies of his or her comments
and presentation slides for distribution
to the FIFRA SAP at the meeting.
3. Seating at the meeting. Seating at
the meeting will be on a first-come
basis.
4. Request for nominations to serve as
ad hoc members of the FIFRA SAP for
this meeting. As part of a broader
process for developing a pool of
candidates for each meeting, the FIFRA
SAP staff routinely solicits the
stakeholder community for nominations
of prospective candidates for service as
ad hoc members of the FIFRA SAP. Any
interested person or organization may
nominate qualified individuals to be
considered as prospective candidates for
a specific meeting. Individuals
nominated for this meeting should have
expertise in one or more of the
following areas: Mammalian (rat)
reproductive endocrinology and
developmental and reproductive
toxicology. Nominees should be
scientists who have sufficient
professional qualifications, including
training and experience, to be capable of
providing expert comments on the
scientific issues for this meeting.
Nominees should be identified by name,
occupation, position, address, and
telephone number. Nominations should
be provided to the DFO listed under FOR
FURTHER INFORMATION CONTACT on or
before December 26, 2006. The Agency
will consider all nominations of
prospective candidates for this meeting
that are received on or before this date.
However, final selection of ad hoc
members for this meeting is a
discretionary function of the Agency.
The selection of scientists to serve on
the FIFRA SAP is based on the function
of the panel and the expertise needed to
address the Agency’s charge to the
panel. No interested scientists shall be
ineligible to serve by reason of their
membership on any other advisory
committee to a Federal department or
agency or their employment by a
Federal department or agency except the
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EPA. Other factors considered during
the selection process include
availability of the potential panel
member to fully participate in the
panel’s reviews, absence of any conflicts
of interest or appearance of lack of
impartiality, independence with respect
to the matters under review, and lack of
bias. Though financial conflicts of
interest, the appearance of lack of
impartiality, lack of independence, and
bias may result in disqualification, the
absence of such concerns does not
assure that a candidate will be selected
to serve on the FIFRA SAP. Numerous
qualified candidates are identified for
each panel. Therefore, selection
decisions involve carefully weighing a
number of factors including the
candidates’ areas of expertise and
professional qualifications and
achieving an overall balance of different
scientific perspectives on the panel. In
order to have the collective breadth of
experience needed to address the
Agency’s charge for this meeting, the
Agency anticipates selecting
approximately 10 ad hoc scientists. If a
prospective candidate for service on the
FIFRA SAP is considered for
participation in a particular session, the
candidate is subject to the provisions of
5 CFR part 2634, Executive Branch
Financial Disclosure, as supplemented
by the EPA in 5 CFR part 6401. As such,
the FIFRA SAP candidate is required to
submit a Confidential Financial
Disclosure Form for Special
Government Employees Serving on
Federal Advisory Committees at the
U.S. Environmental Protection Agency
(EPA Form 3110-48 [5-02]) which shall
fully disclose, among other financial
interests, the candidate’s employment,
stocks and, bonds, and where
applicable, sources of research support.
The EPA will evaluate the candidates
financial disclosure form to assess
whether there are financial conflicts of
interest, appearance of a lack of
impartiality or any prior involvement
with the development of the documents
under consideration (including previous
scientific peer review) before the
candidate is considered further for
service on the FIFRA SAP. Those who
are selected from the pool of prospective
candidates will be asked to attend the
public meetings and to participate in the
discussion of key issues and
assumptions at these meetings. In
addition, they will be asked to review
and to help finalize the meeting
minutes. The list of FIFRA SAP
members participating at this meeting
will be posted on the FIFRA SAP web
site at https://epa.gov/scipoly/sap or may
be obtained from the OPP Regulatory
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74903
Public Docket at https://
www.regulations.gov.
II. Background
A. Purpose of the FIFRA SAP
The FIFRA SAP serves as the primary
scientific peer review mechanism of the
United States Environmental Protection
Agency (EPA), Office of Prevention,
Pesticides and Toxic Substances and is
structured to provide scientific advice,
information and recommendations to
the EPA Administrator on pesticides
and pesticide-related issues as to the
impact of regulatory actions on health
and the environment. The FIFRA SAP is
a Federal advisory committee
established in 1975 under the Federal
Insecticide, Fungicide and Rodenticide
Act that operates in accordance with
requirements of the Federal Advisory
Committee Act. The FIFRA SAP is
composed of a permanent panel
consisting of seven members who are
appointed by the EPA Administrator
from nominees provided by the National
Institutes of Health and the National
Science Foundation. FIFRA, as
amended by the 1996 Food Quality
Protection Act, established a Science
Review Board consisting of at least 60
scientists who are available to the
Scientific Advisory Panel on an ad hoc
basis to assist in reviews conducted by
the Panel. As a peer review mechanism,
the FIFRA SAP provides comments,
evaluations and recommendations to
improve the effectiveness and quality of
analyses made by Agency scientists.
Members of the FIFRA SAP are
scientists who have sufficient
professional qualifications, including
training and experience, to provide
expert advice and recommendations to
the Agency.
B. Public Meeting
The EPA is implementing the
Endocrine Disruptor Screening Program
(EDSP) in response to a 1996
Congressional mandate in the Federal
Food, Drug, and Cosmetic Act (FFDCA)
to establish a screening program using
validated assays to identify pesticides
that may have estrogenic effects in
humans and other endocrine effects, as
designated by the EPA Administrator.
The Agency also has authority to
include other non-pesticide chemicals
that have an effect cumulative to that of
a pesticide to which a substantial
human population may be exposed. In
developing the EDSP, the EPA
considered the recommendations of the
Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC),
a panel chartered pursuant to the
Federal Advisory Committee Act
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(FACA). The screening program was
also reviewed by EPA’s Science
Advisory Board and by the Scientific
Advisory Panel (SAB/SAP), as required
by the FFDCA. It was recommended that
the EPA address both human and
ecological effects and examine effects to
estrogen, androgen, and thyroid (EAT)
related processes, and that a two-tiered
approach be used for screening. The
purpose of the Tier-1 battery is to
identify substances that have the
potential to interact with the endocrine
system. The purpose of Tier 2 is to
confirm the interaction, identify any
adverse effects, and establish
quantitative relationships between dose
and adverse effects.
Both the EDSTAC and SAB/SAP
recognized the importance of chemical
exposure during development in utero
as well as during lactation and,
therefore, recommended an in utero
through lactational animal model to
detect effects that may result from preand postnatal exposure. The EDSTAC
and SAB/SAP also recommended that
any in utero through lactational
bioassay should be developed in a way
that would allow for replacement of one
or more of the other assays proposed for
the Tier-1 screening battery.
The EDSP commissioned an in utero
through lactational Detailed Review
Paper (DRP) that consisted of an
extensive review of the scientific
literature regarding chemicals known to
disrupt the EAT hormone systems
during pre- and postnatal development.
The DRP presented three in utero
through lactational bioassay protocols
for the EDSP to consider. The EPA
presented the DRP and its
recommendations to the Endocrine
Disruptor Methods Validation
Subcommittee (EDMVS) for review and
discussion. The most comprehensive of
the three protocols was chosen and
tested with methoxychlor, a positive
compound that is known to have
estrogenic, anti-estrogenic and antiandrogenic effects. In general, the
EDMVS agreed with this pre-validation
approach with the expectation that the
EPA would return to a federal advisory
committee such as the SAP to review
and discuss the results of the in utero
through lactational study with
methoxychlor.
The purpose of this meeting is to
allow the SAP to review and discuss the
protocol and assay results of an in utero
through lactational study with
methoxychlor within the current
context of the EDSP and to provide
advice that will inform the EPA’s
decision to continue, modify or suspend
the development of an in utero through
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lactational bioassay as a screening assay
in a Tier-1 battery.
C. FIFRA SAP Documents and Meeting
Minutes.
EPA’s background materials, charge/
questions to the FIFRA SAP, FIFRA SAP
composition (i.e., members and ad hoc
members for this meeting), and the
meeting agenda will be available by late
January 2007. In addition, the Agency
may provide additional background
documents as the materials become
available. You may obtain electronic
copies of these documents, and certain
other related documents that might be
available electronically, at https://
www.regulations.gov and the FIFRA
SAP homepage at https://www.epa.gov/
scipoly/sap.
The FIFRA SAP will prepare meeting
minutes summarizing its
recommendations to the Agency
approximately 90 days after the
meeting. The meeting minutes will be
posted on the FIFRA SAP web site or
may be obtained from the OPP
Regulatory Public Docket at https://
www.regulations.gov.
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: December 7, 2006.
Elizabeth A. Resek,
Director, Office of Science Coordination and
Policy.
[FR Doc. E6–21201 Filed 12–12–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA-HQ-OPP-2005-0098; FRL–8107–1]
Ethyl Parathion; Product Cancellation
Order
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces EPA’s
order for the cancellations, voluntarily
requested by the Drexel Chemical
Company and accepted by the Agency,
of products containing the pesticide
ethyl parathion, pursuant to section
6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), as amended. This cancellation
order follows April 27, 2005 Federal
Register Notice of Receipt of Requests
from the ethyl parathion registrant to
voluntarily cancel all their ethyl
parathion product registrations. These
are the last ethyl parathion products
registered for use in the United States.
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In the April 27, 2005 Notice, EPA
indicated that it would issue an order
implementing the cancellations and/or
amendments to terminate uses, unless
the Agency received substantive
comments within the 30–day comment
period that would merit its further
review of these requests, or unless the
registrants withdrew their requests
within this period. The Agency did not
receive any comments on the Notice.
Further, the registrant did not withdraw
their requests. Accordingly, EPA hereby
issues in this notice a cancellation order
granting the requested cancellations.
Any distribution, sale, or use of the
ethyl parathion products subject to this
cancellation order is permitted only in
accordance with the terms of this order,
including any existing stocks
provisions.
DATES: The cancellations are effective
December 13, 2006.
FOR FURTHER INFORMATION CONTACT:
Laura Parsons, Special Review and
Reregistration Division (7508P), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001;
telephone number: (703) 305-5776; fax
number: (703) 305-8005; e-mail address:
parsons.laura@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public
in general, and may be of interest to a
wide range of stakeholders including
environmental, human health, and
agricultural advocates; the chemical
industry; pesticide users; and members
of the public interested in the sale,
distribution, or use of pesticides. Since
others also may be interested, the
Agency has not attempted to describe all
the specific entities that may be affected
by this action. If you have any questions
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this
Document and Other Related
Information?
1. Docket. EPA has established a
docket for this action under docket
identification (ID) number EPA-HQOPPT-2005-0098. Publicly available
docket materials are available either in
the electronic docket at https://
www.regulations.gov, or, if only
available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive Arlington, VA. The hours
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]]>Agencies
[Federal Register Volume 71, Number 239 (Wednesday, December 13, 2006)]
[Notices]
[Pages 74901-74904]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21201]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-0987; FRL-8107-9]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: There will be a 2-day meeting of the Federal Insecticide,
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to
consider and review the status of the in utero through lactational
assay in the Endocrine Disruptor Screening Program (EDSP).
DATES: The meeting will be held on February 27-28, 2007, from 8:30 a.m.
to 5 p.m, eastern time.
Comments: The Agency encourages submission of written comments by
February 13, 2007 and requests for oral comments by February 20, 2007.
However, written comments and requests to make oral comments may be
submitted until the date of the meeting. For additional instructions,
see Unit I.C. of the SUPPLEMENTARY INFORMATION.
Nominations: Nominations of candidates to serve as ad hoc members
of the FIFRA SAP for this meeting should be provided on or before
December 26, 2006.
Special Accommodations: For information on access or services for
individuals with disabilities, and to request accommodation of a
disability, please contact the Designated Federal Official (DFO) listed
under FOR FURTHER INFORMATION CONTACT at least 10 days prior to the
meeting to give EPA as much time as possible to process your request.
[[Page 74902]]
ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Conference Center - Lobby Level, One Potomac Yard (South
Bldg.), 2777 S. Crystal Drive, Arlington, VA 22202.
Comments: Submit your comments, identified by docket ID number EPA-
HQ-OPP-2006-0987, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments. Your use of
the Federal eRulemaking Portal to submit comments to EPA electronically
is EPA's preferred method for receiving comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., N.W., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0987. If your comments contain any information that you consider
to be CBI or otherwise protected, please contact the DFO listed under
FOR FURTHER INFORMATION CONTACT to obtain special instruction before
submitting your comments. EPA's policy is that all comments received
will be included in the docket without change and may be made available
on-line at https://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
regulations.gov or e-mail. The regulations.gov website is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket are listed in a docket index
that is available at https://www.regulations.gov. Although listed in a
docket index, some information is not publicly available, e.g., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg), 2777 S. Crystal Drive, Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket telephone number
is (703) 305-5805.
Nominations, requests to present oral comments, and requests for
special accommodations: Submit nominations to serve as an ad hoc member
of the FIFRA SAP, requests for special seating accommodations, or
requests to present oral comments to the DFO listed under FOR FURTHER
INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: William Wooge, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-
564-8476; fax number: 202-564-8382; e-mail addresses:
wooge.william@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of
1996 (FQPA). Since other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the DFO
listed under FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
Tips for preparing your comments. When submitting comments,
remember to:
1. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
2. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
4. Describe any assumptions and provide any technical information
and/or data that you used.
5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
6. Provide specific examples to illustrate your concerns and
suggest alternatives.
7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
8. Make sure to submit your comments by the comment period deadline
identified.
C. How May I Participate in this Meeting?
You may participate in this meeting by following the instructions
in this unit. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-OPP-2006-0987 in the subject line
on the first page of your request.
1. Written comments. The Agency encourages that written comments be
submitted, using the instructions in ADDRESSES, no later than February
13, 2007, to provide FIFRA SAP the time necessary to consider and
review the written comments. However, written comments are accepted
until the date of the meeting. Persons wishing to submit written
comments at the meeting should contact the DFO listed under FOR FURTHER
INFORMATION CONTACT and submit 30 copies. There is no limit on the
extent of written comments for consideration by FIFRA SAP.
2. Oral comments. The Agency encourages that each individual or
group wishing to make brief oral comments to the FIFRA SAP submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no
later than February 20, 2007, in order to be included on the meeting
agenda.
[[Page 74903]]
Requests to present oral comments will be accepted until the date of
the meeting and, to the extent that time permits, the Chair of the
FIFRA SAP may permit the presentation of oral comments at the meeting
by interested persons who have not previously requested time. The
request should identify the name of the individual making the
presentation, the organization (if any) the individual will represent,
and any requirements for audiovisual equipment (e.g., overhead
projector, 35 mm projector, chalkboard). Oral comments before FIFRA SAP
are limited to approximately 5 minutes unless prior arrangements have
been made. In addition, each speaker should bring 30 copies of his or
her comments and presentation slides for distribution to the FIFRA SAP
at the meeting.
3. Seating at the meeting. Seating at the meeting will be on a
first-come basis.
4. Request for nominations to serve as ad hoc members of the FIFRA
SAP for this meeting. As part of a broader process for developing a
pool of candidates for each meeting, the FIFRA SAP staff routinely
solicits the stakeholder community for nominations of prospective
candidates for service as ad hoc members of the FIFRA SAP. Any
interested person or organization may nominate qualified individuals to
be considered as prospective candidates for a specific meeting.
Individuals nominated for this meeting should have expertise in one or
more of the following areas: Mammalian (rat) reproductive endocrinology
and developmental and reproductive toxicology. Nominees should be
scientists who have sufficient professional qualifications, including
training and experience, to be capable of providing expert comments on
the scientific issues for this meeting. Nominees should be identified
by name, occupation, position, address, and telephone number.
Nominations should be provided to the DFO listed under FOR FURTHER
INFORMATION CONTACT on or before December 26, 2006. The Agency will
consider all nominations of prospective candidates for this meeting
that are received on or before this date. However, final selection of
ad hoc members for this meeting is a discretionary function of the
Agency.
The selection of scientists to serve on the FIFRA SAP is based on
the function of the panel and the expertise needed to address the
Agency's charge to the panel. No interested scientists shall be
ineligible to serve by reason of their membership on any other advisory
committee to a Federal department or agency or their employment by a
Federal department or agency except the EPA. Other factors considered
during the selection process include availability of the potential
panel member to fully participate in the panel's reviews, absence of
any conflicts of interest or appearance of lack of impartiality,
independence with respect to the matters under review, and lack of
bias. Though financial conflicts of interest, the appearance of lack of
impartiality, lack of independence, and bias may result in
disqualification, the absence of such concerns does not assure that a
candidate will be selected to serve on the FIFRA SAP. Numerous
qualified candidates are identified for each panel. Therefore,
selection decisions involve carefully weighing a number of factors
including the candidates' areas of expertise and professional
qualifications and achieving an overall balance of different scientific
perspectives on the panel. In order to have the collective breadth of
experience needed to address the Agency's charge for this meeting, the
Agency anticipates selecting approximately 10 ad hoc scientists. If a
prospective candidate for service on the FIFRA SAP is considered for
participation in a particular session, the candidate is subject to the
provisions of 5 CFR part 2634, Executive Branch Financial Disclosure,
as supplemented by the EPA in 5 CFR part 6401. As such, the FIFRA SAP
candidate is required to submit a Confidential Financial Disclosure
Form for Special Government Employees Serving on Federal Advisory
Committees at the U.S. Environmental Protection Agency (EPA Form 3110-
48 [5-02]) which shall fully disclose, among other financial interests,
the candidate's employment, stocks and, bonds, and where applicable,
sources of research support. The EPA will evaluate the candidates
financial disclosure form to assess whether there are financial
conflicts of interest, appearance of a lack of impartiality or any
prior involvement with the development of the documents under
consideration (including previous scientific peer review) before the
candidate is considered further for service on the FIFRA SAP. Those who
are selected from the pool of prospective candidates will be asked to
attend the public meetings and to participate in the discussion of key
issues and assumptions at these meetings. In addition, they will be
asked to review and to help finalize the meeting minutes. The list of
FIFRA SAP members participating at this meeting will be posted on the
FIFRA SAP web site at https://epa.gov/scipoly/sap or may be obtained
from the OPP Regulatory Public Docket at https://www.regulations.gov.
II. Background
A. Purpose of the FIFRA SAP
The FIFRA SAP serves as the primary scientific peer review
mechanism of the United States Environmental Protection Agency (EPA),
Office of Prevention, Pesticides and Toxic Substances and is structured
to provide scientific advice, information and recommendations to the
EPA Administrator on pesticides and pesticide-related issues as to the
impact of regulatory actions on health and the environment. The FIFRA
SAP is a Federal advisory committee established in 1975 under the
Federal Insecticide, Fungicide and Rodenticide Act that operates in
accordance with requirements of the Federal Advisory Committee Act. The
FIFRA SAP is composed of a permanent panel consisting of seven members
who are appointed by the EPA Administrator from nominees provided by
the National Institutes of Health and the National Science Foundation.
FIFRA, as amended by the 1996 Food Quality Protection Act, established
a Science Review Board consisting of at least 60 scientists who are
available to the Scientific Advisory Panel on an ad hoc basis to assist
in reviews conducted by the Panel. As a peer review mechanism, the
FIFRA SAP provides comments, evaluations and recommendations to improve
the effectiveness and quality of analyses made by Agency scientists.
Members of the FIFRA SAP are scientists who have sufficient
professional qualifications, including training and experience, to
provide expert advice and recommendations to the Agency.
B. Public Meeting
The EPA is implementing the Endocrine Disruptor Screening Program
(EDSP) in response to a 1996 Congressional mandate in the Federal Food,
Drug, and Cosmetic Act (FFDCA) to establish a screening program using
validated assays to identify pesticides that may have estrogenic
effects in humans and other endocrine effects, as designated by the EPA
Administrator. The Agency also has authority to include other non-
pesticide chemicals that have an effect cumulative to that of a
pesticide to which a substantial human population may be exposed. In
developing the EDSP, the EPA considered the recommendations of the
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC),
a panel chartered pursuant to the Federal Advisory Committee Act
[[Page 74904]]
(FACA). The screening program was also reviewed by EPA's Science
Advisory Board and by the Scientific Advisory Panel (SAB/SAP), as
required by the FFDCA. It was recommended that the EPA address both
human and ecological effects and examine effects to estrogen, androgen,
and thyroid (EAT) related processes, and that a two-tiered approach be
used for screening. The purpose of the Tier-1 battery is to identify
substances that have the potential to interact with the endocrine
system. The purpose of Tier 2 is to confirm the interaction, identify
any adverse effects, and establish quantitative relationships between
dose and adverse effects.
Both the EDSTAC and SAB/SAP recognized the importance of chemical
exposure during development in utero as well as during lactation and,
therefore, recommended an in utero through lactational animal model to
detect effects that may result from pre- and postnatal exposure. The
EDSTAC and SAB/SAP also recommended that any in utero through
lactational bioassay should be developed in a way that would allow for
replacement of one or more of the other assays proposed for the Tier-1
screening battery.
The EDSP commissioned an in utero through lactational Detailed
Review Paper (DRP) that consisted of an extensive review of the
scientific literature regarding chemicals known to disrupt the EAT
hormone systems during pre- and postnatal development. The DRP
presented three in utero through lactational bioassay protocols for the
EDSP to consider. The EPA presented the DRP and its recommendations to
the Endocrine Disruptor Methods Validation Subcommittee (EDMVS) for
review and discussion. The most comprehensive of the three protocols
was chosen and tested with methoxychlor, a positive compound that is
known to have estrogenic, anti-estrogenic and anti-androgenic effects.
In general, the EDMVS agreed with this pre-validation approach with the
expectation that the EPA would return to a federal advisory committee
such as the SAP to review and discuss the results of the in utero
through lactational study with methoxychlor.
The purpose of this meeting is to allow the SAP to review and
discuss the protocol and assay results of an in utero through
lactational study with methoxychlor within the current context of the
EDSP and to provide advice that will inform the EPA's decision to
continue, modify or suspend the development of an in utero through
lactational bioassay as a screening assay in a Tier-1 battery.
C. FIFRA SAP Documents and Meeting Minutes.
EPA's background materials, charge/questions to the FIFRA SAP,
FIFRA SAP composition (i.e., members and ad hoc members for this
meeting), and the meeting agenda will be available by late January
2007. In addition, the Agency may provide additional background
documents as the materials become available. You may obtain electronic
copies of these documents, and certain other related documents that
might be available electronically, at https://www.regulations.gov and
the FIFRA SAP homepage at https://www.epa.gov/scipoly/sap.
The FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency approximately 90 days after the meeting.
The meeting minutes will be posted on the FIFRA SAP web site or may be
obtained from the OPP Regulatory Public Docket at https://
www.regulations.gov.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: December 7, 2006.
Elizabeth A. Resek,
Director, Office of Science Coordination and Policy.
[FR Doc. E6-21201 Filed 12-12-06; 8:45 am]
BILLING CODE 6560-50-S
